Kalbitor — Class II drug recall D-0625-2017
Terminated recall by Shire, reported 2017-04-12, distributed nationwide. Presence of Particulate Matter: Glass
| Recall number | D-0625-2017 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Shire, Lexington, MA, United States |
| Recall initiated | 2017-03-17 |
| Classified | 2017-03-31 |
| Reported by FDA | 2017-04-12 |
| Terminated | 2021-05-25 |
| Distributed | Nationwide (US) |
| Countries outside the US | KW |
| Reason classes | foreign material, specification failure |
| NDC | 47783-0101, 47783-0101-01 |
| Lot numbers | A1500009 |
| Expiration dates | 2019-01-31 |
Product
Kalbitor (ecallantide), 10mg/mL, packaged in 3 vials per Carton, Rx Only, Dynax Corp., Burlington, MA. NDC47783-101-01
Reason for recall
Presence of Particulate Matter: Glass
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-0625-2017. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.